510(k) · Cleared
ClearedIPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nalu Medical, Inc. · GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Cleared on Sep 6, 2019 as substantially equivalent to K183579 (Boston Scientific Neuromodulation, 2019) after a 99-day review. Its family tree reaches back 8 generations to 1988.
- Decided
- Sep 6, 2019
- Review
- 99 days
- Class
- Class II
- Product code
- GZF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K883780 (1988). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK883780 Xtrel, Model Number 3425Medtronic Vascular · 1988
- 7 generations backK141399 Freedom Spinal Cord Stimulator (SCS) SystemStimwave Technologies Incorporated · 2014
- 6 generations backK150517 Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated · 2015
- 5 generations backK160600 Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated · 2016
- 4 generations backK162161 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit…Stimwave Technologies Incorporated · 2016
- 3 generations backK170141 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit…Stimwave Technologies Incorporated · 2017
- 2 generations backK171366 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG…Stimwave Technologies Inc., Dba Stimq, LLC · 2017 · Recalled
- 1 generation backK183579 Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu…Boston Scientific Neuromodulation · 2019 · Recalled
- This deviceK191435 IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead…Nalu Medical, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K883780 | Xtrel, Model Number 3425 | Medtronic Vascular | 1988 | — |
| −7 | K141399 | Freedom Spinal Cord Stimulator (SCS) System | Stimwave Technologies Incorporated | 2014 | — |
| −6 | K150517 | Freedom Spinal Cord Stimulator System | Stimwave Technologies Incorporated | 2015 | — |
| −5 | K160600 | Freedom Spinal Cord Stimulator System | Stimwave Technologies Incorporated | 2016 | — |
| −4 | K162161 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable… | Stimwave Technologies Incorporated | 2016 | — |
| −3 | K170141 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable… | Stimwave Technologies Incorporated | 2017 | — |
| −2 | K171366 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG… | Stimwave Technologies Inc., Dba Stimq, LLC | 2017 | 6 |
| −1 | K183579 | Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu… | Boston Scientific Neuromodulation | 2019 | 1 |
| 0 (this device) | K191435 | IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm… | Nalu Medical, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GZF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GZF device
- #1 K243782 StimTrial Neuromodulation Systemscore 11.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K183579 | Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation…Summary page 4…(Pain Relief) Class: Class II Device Classification Panel: Neurology Legally Marketed Predicate Device(s) Nalu Neurostimulation System for Peripheral Nerve Stimulation (K183579) For areas where slight differences occur between the Nalu Neurostimulation system and the primary predicate (K183579), substant… | 2019 |
| † | K171366 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory… | 2017 |
| † | K152178 | StimQ Peripheral Nerve Stimulator (PNS) System | 2016 |
| † | K150517 | Freedom Spinal Cord Stimulator System | 2015 |
| † | K934065 | Medtronic Mattrix 3271/3272 Neurostimulation System | 1995 |
| † | K883780 | Xtrel, Model Number 3425 | 1988 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 5 companies; a new generation was cleared every 8 months on median.
- 3 of the 11 ancestors have a recall of any class.
- 4 other devices also cite its predicate K183579.
How does its category compare?
All GZF devicesGZF Stimulator, Peripheral Nerve, Implanted (Pain Relief): FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · GZF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZF
99in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZF
No recall names GZF since 2007.
Adverse event reports per year · GZF
597in 2025
MAUDE reports naming product code GZF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 7 |
| 2008 | 0 | — | 0 | 13 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 0 | — | 0 | 24 |
| 2011 | 0 | — | 0 | 17 |
| 2012 | 0 | — | 0 | 12 |
| 2013 | 0 | — | 0 | 77 |
| 2014 | 0 | — | 0 | 268 |
| 2015 | 1 | — | 0 | 346 |
| 2016 | 1 | — | 0 | 414 |
| 2017 | 1 | — | 0 | 330 |
| 2018 | 0 | — | 0 | 318 |
| 2019 | 3 | 99 | 0 | 64 |
| 2020 | 2 | — | 0 | 104 |
| 2021 | 1 | — | 0 | 226 |
| 2022 | 1 | — | 0 | 183 |
| 2023 | 1 | — | 0 | 524 |
| 2024 | 2 | — | 0 | 678 |
| 2025 | 2 | — | 0 | 597 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
This system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The system is not intended to treat pain in the craniofacial region.
The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191435 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191435: IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191435
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026